1. Field of the Invention
The invention relates to extrudable elastic oral pharmaceutical gel compositions and metered dose dispensers containing them and method of making and method of use thereof.
2. Information Disclosure Statement
Cohen et al. U.S. Pat. No. 4,708,834 issued Nov. 24, 1987 describes pharmaceutical gel compositions as fills for gelatin capsules. The fill compositions are described as "comprising an aqueous solution or dispersion of a polysaccharide gum and a pharmaceutically-active compound". Most of the water thereof is described as being removed after encapsulation by drying the capsules. Acetaminophen and niacin fill compositions and capsules are specifically described.
There is a need for oral pharmaceutical compositions for pediatric and adult/geriatric use in an easy to use metered dose form. An attempt to fill this need is shown by Mackles U.S. Pat. No. 4,639,367 issued Jan. 27, 1987, which describes "stable, edible anhydrous aerosol foam[s] or whip[s] capable of suspending up to 50% by weight of a dispersed solid . . . prepared from a foamable, edible anhydrous liquid oil; a foaming agent; and controlled amounts of a food grade propellant which are sufficient to produce a stable foam rather than a spray." Such products appear to be illustrated by Extra Strength MAALOX.RTM. WHIP.TM. Antacid brand of magnesium and aluminum hydroxides oral suspension, which is described by Physicians' Desk Reference for Nonprescription Drugs (ninth edition, 1988, pp. 423 and 667). These compositions suffer the disadvantages of high caloric content due to the edible oil, potential for gastric and intestinal distress due to the aerosol propellant, inexact metering and tendency for the aerosol dispenser nozzle to clog due to the particulate nature of the compositions. The presently described and claimed invention overcomes all of these disadvantages.